Gaucher Disease Outcome Survey (GOS)
| Status: | Recruiting |
|---|---|
| Conditions: | Metabolic |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/21/2019 |
| Start Date: | July 27, 2010 |
| End Date: | December 1, 2020 |
| Contact: | Shire Contact |
| Email: | ClinicalTransparency@shire.com |
| Phone: | +1 866 842 5335 |
The Gaucher Outcomes Survey (GOS) is an ongoing observational, international, multi-center,
long-term Registry of Patients with Gaucher Disease irrespective of their treatment status or
type of treatment received. No experimental intervention is involved. Patients undergo
clinical assessments and receive care as determined by the patients' treating physician.
The objectives of the registry include to evaluate the safety and long-term effectiveness of
velaglucerase alfa, to characterize patients receiving velaglucerase alfa or other Gaucher
Disease-specific treatments, to gain a better understanding of the natural history of GD and
to serve as a database for evidence-based management of Gaucher Disease over time in
real-life clinical practice.
long-term Registry of Patients with Gaucher Disease irrespective of their treatment status or
type of treatment received. No experimental intervention is involved. Patients undergo
clinical assessments and receive care as determined by the patients' treating physician.
The objectives of the registry include to evaluate the safety and long-term effectiveness of
velaglucerase alfa, to characterize patients receiving velaglucerase alfa or other Gaucher
Disease-specific treatments, to gain a better understanding of the natural history of GD and
to serve as a database for evidence-based management of Gaucher Disease over time in
real-life clinical practice.
Inclusion Criteria:
- Patients of any age or gender with confirmed diagnosis (biochemical and/or genetic) of
Gaucher disease
- Signed and dated written informed consent from the patient or, for patients aged <18
years (<16 years in the United Kingdom [UK]), their parent and/or legally authorized
representatives (LAR), and assent of the minor where applicable. Legally authorized
representatives are also applicable for cognitively impaired patients.
Exclusion Criteria:
- Patients currently enrolled in ongoing blinded clinical trials (drugs or devices;
includes all blinded trials)
We found this trial at
1
site
21 Worthen Road
Lexington, Massachusetts 02421
Lexington, Massachusetts 02421
Principal Investigator: Central Contact
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